Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis

Multicenter randomized controlled trial of LGG in patients 3-48 months of age presenting to
the Emergency Department with acute gastroenteritis.

Inclusion Criteria:

1. Age 3-48 months (have not yet reached their fourth birthday); AND

2. Presence of 3 or more watery stools within 24 hours of screening; AND

3. Duration of vomiting or diarrhea less than 7 days; AND

4. Symptoms consistent with acute intestinal infectious process.

Exclusion Criteria:

1. Presence of an indwelling vascular access line; OR

2. Presence of structural heart disease excluding non-pathological heart murmurs; OR

3. Receiving immunosuppressive therapy or history of immunodeficiency; OR

4. Hematochezia in the preceding 48 hours; OR

5. Chronic gastrointestinal problems (e.g. short gut syndrome, inflammatory bowel
disease); OR

6. Patients with known pancreatitis; OR

7. History of abdominal surgery; OR

8. Critically ill patients; OR

9. Family member with an indwelling vascular access line, or on immunosuppressive
therapy, or with a known immunodeficiency; OR

10. Bilious emesis; OR

11. Probiotic use (supplement) in the preceding 2 weeks; OR

12. Oral or intravenous steroid use in the preceding six months; OR

13. Previously enrolled in this trial; OR

14. Allergy to lactobacillus or Microcrystalline Cellulose (MCC); OR

15. Allergy to erythromycin, clindamycin, AND betalactam antibiotics (all); OR

16. Not available for daily follow-up while symptomatic; OR

17. Parent/guardian not speaking English or Spanish; OR

18. Under 6 months old AND premature (<37 weeks).